TAZAROTENE

Product NDC
72162-2202
11-digit product format
721622202
Labeler code
72162
Product ID
72162-2202_7fbab766-c3aa-45d8-a298-321e19bc6104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
GEL
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA213079
Marketing category
ANDA
Marketing start
2023-06-05
Substance
TAZAROTENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213079-001TAZAROTENETAZAROTENE0.05%GEL / TOPICALAB2023-04-25
A213079-002TAZAROTENETAZAROTENE0.1%GEL / TOPICALAB2023-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A213079-001AB
A213079-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25caaa826d4ba7…
2026-08-18 06:07:402026-07A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-256a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-251c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-25a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213079-001TAZAROTENE0.05%GEL / TOPICALAB2023-04-259b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213079-002TAZAROTENE0.1%GEL / TOPICALAB2023-04-259b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213079-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213079-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213079-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213079-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213079-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213079-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213079-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213079-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213079-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213079-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213079-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213079-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213079-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213079-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213079-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213079-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213079-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213079-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213079-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213079-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213079-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213079-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213079-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213079-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213079-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213079-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213079-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213079-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213079-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213079-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213079-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213079-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213079-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213079-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213079-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213079-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213079-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213079-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213079-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213079-002AB19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
TAZAROTENE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZAROTENE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81BDR9Y8PSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313201Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa6fff2f-01c7-4669-be67-07cec82c768aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2202-3TAZAROTENE30 g in 1 TUBEGEL30101
72162-2202-3TAZAROTENE1 in 1 CARTONGEL1101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2202-3GM - Gram72162-2202a15aabc2-d5fd-4984-a100-cf30317a94a612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2202TAZAROTENE GEL [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240601_aa6fff2f-01c7-4669-be67-07cec82c768a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TAZAROTENETAZAROTENEBryant Ranch Prepackaa6fff2f-01c7-4669-be67-07cec82c768a2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213079
application number: ANDA213079
ndc (product): 72162-2202
TAZAROTENETAZAROTENEPadagis Israel Pharmaceuticals Ltdffd11dee-4266-4201-9573-1e82c2d30a632024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213079
application number: ANDA213079

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313201tazarotene 0.1 % Topical GelPSNaa6fff2f-01c7-4669-be67-07cec82c768a101
313201tazarotene 0.001 MG/MG Topical GelSCDaa6fff2f-01c7-4669-be67-07cec82c768a101
313201tazarotene 0.1 % Topical GelSYaa6fff2f-01c7-4669-be67-07cec82c768a101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2202-3721622202031 TUBE in 1 CARTON (72162-2202-3) / 30 g in 1 TUBE1 tube2023-06-05NoNoCurrent